Trial · NCT04171700
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
NCT04171700, Phase 2, Terminated, pharmaand GmbH; results first posted 2023-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes. Trials, record NCT04171700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04171700
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
- NCT number
- NCT04171700
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- pharmaand GmbH
- Conditions
- Solid Tumor
- Interventions
- Rucaparib
- First posted
- 2019-11-21
- Last updated
- 2023-10-02
- Results first posted
- 2023-10-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate by Investigator | From first dose of study drug until disease progression (up to approximately 2 years) | Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer). |
| Secondary | Overall Response Rate by Independent Radiology Review | From first dose of study drug until disease progression (up to approximately 2 years) | Best overall response rate by independent radiology review by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer). |
| Secondary | Duration of Response | From first dose of study drug until disease progression (up to approximately 2 years) | Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression. |
| Secondary | Disease Control Rate | From first dose of study drug until disease progression (up to approximately 2 years) | Measure of clinical benefit, defined as the percentage of complete response (CR), partial response (PR), and stable disease (SD) beyond 16 weeks. |
| Secondary | Progression-free Survival | From first dose of study drug until disease progression (up to approximately 2 years) | Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated. |
| Secondary | Overall Survival | From first dose of study drug until disease progression (up to approximately 2 years) | Measure of clinical benefit, defined as the duration from study enrollment to death. |
| Secondary | Number of Participants Experiencing Treatment-emergent Adverse Events | From first dose of study drug until disease progression (up to approximately 2 years) | |
| Secondary | Steady State Minimum Concentration [Cmin] | From first dose of study drug until disease progression (up to approximately 2 years) | Rucaparib pharmacokinetics |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate by Investigator | From first dose of study drug until disease progression (up to approximately 2 years) | Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate by Independent Radiology Review | From first dose of study drug until disease progression (up to approximately 2 years) | No data were collected as the independent radiology review was not performed. | ||
| SECONDARY | Duration of Response | From first dose of study drug until disease progression (up to approximately 2 years) | Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants). | month | MEDIAN |
| SECONDARY | Disease Control Rate | From first dose of study drug until disease progression (up to approximately 2 years) | Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants). | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival | From first dose of study drug until disease progression (up to approximately 2 years) | Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment. | month | MEDIAN |
| SECONDARY | Overall Survival | From first dose of study drug until disease progression (up to approximately 2 years) | Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment. | month | MEDIAN |
| SECONDARY | Number of Participants Experiencing Treatment-emergent Adverse Events | From first dose of study drug until disease progression (up to approximately 2 years) | Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Steady State Minimum Concentration [Cmin] | From first dose of study drug until disease progression (up to approximately 2 years) | Pharmacokinetics data not collected due to early study termination. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate by Investigator | Rucaparib Cohort A | 9 | Participants | ||
| Best Overall Response Rate by Investigator | Rucaparib Cohort B | 2 | Participants | ||
| Duration of Response | Rucaparib Cohort A | 4.1 | 95% Confidence Interval 3.1 to NA | month | |
| Duration of Response | Rucaparib Cohort B | 6.8 | 95% Confidence Interval 2.6 to 10.9 | month | |
| Disease Control Rate | Rucaparib Cohort A | 36.1 | 95% Confidence Interval 24.2 to 49.4 | percentage of participants | |
| Disease Control Rate | Rucaparib Cohort B | 25.0 | 95% Confidence Interval 8.7 to 49.1 | percentage of participants | |
| Progression-free Survival | Rucaparib Cohort A | 3.7 | 95% Confidence Interval 1.9 to 5.4 | month | |
| Progression-free Survival | Rucaparib Cohort B | 3.6 | 95% Confidence Interval 1.6 to 6.3 | month | |
| Overall Survival | Rucaparib Cohort A | 13.3 | 95% Confidence Interval 10.6 to NA | month | |
| Overall Survival | Rucaparib Cohort B | 8.0 | 95% Confidence Interval 4.8 to 16.6 | month |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rucaparib Cohort A | 63 | |
| Overall Study | STARTED | Rucaparib Cohort B | 20 | |
| Overall Study | COMPLETED | Rucaparib Cohort A | 63 | |
| Overall Study | COMPLETED | Rucaparib Cohort B | 20 | |
| Overall Study | NOT COMPLETED | Rucaparib Cohort A | 0 | |
| Overall Study | NOT COMPLETED | Rucaparib Cohort B | 0 |
Source ClinicalTrials.gov
Adverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Rucaparib Cohort A | 20 | 63 | |
| other | Anemia | Blood and lymphatic system disorders | Rucaparib Cohort B | 5 | 20 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rucaparib Cohort A | 3 | 63 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rucaparib Cohort B | 0 | 20 | |
| other | Bradycardia | Cardiac disorders | Rucaparib Cohort A | 2 | 63 | |
| other | Bradycardia | Cardiac disorders | Rucaparib Cohort B | 1 | 20 | |
| other | Abdominal distension | Gastrointestinal disorders | Rucaparib Cohort A | 4 | 63 | |
| other | Abdominal distension | Gastrointestinal disorders | Rucaparib Cohort B | 1 | 20 | |
| other | Abdominal pain | Gastrointestinal disorders | Rucaparib Cohort A | 7 | 63 | |
| other | Abdominal pain | Gastrointestinal disorders | Rucaparib Cohort B | 4 | 20 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rucaparib Cohort A | 23 | 63 |
| Total, all-cause mortality | Rucaparib Cohort B | 10 | 20 |
| Total, other adverse events | Rucaparib Cohort A | 63 | 63 |
| Total, other adverse events | Rucaparib Cohort B | 19 | 20 |
| Total, serious adverse events | Rucaparib Cohort A | 13 | 63 |
| Total, serious adverse events | Rucaparib Cohort B | 5 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40632975 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rucaparib Cohort A vs Rucaparib Cohort B: Number of Participants Experiencing Treatment-emergent Adverse Events | Trial comparisons |
| Rucaparib Cohort A vs Rucaparib Cohort B: Best Overall Response Rate by Investigator | Trial comparisons |
| Rucaparib Cohort A vs Rucaparib Cohort B: deaths from any cause | Trial comparisons |
| Rucaparib Cohort A vs Rucaparib Cohort B: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04171700
GET https://conductscience.org/api/trials/v1/NCT04171700/events?page=2